Senior QA IT Lead – GxP Systems & Compliance

AstraZeneca plc; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

AstraZeneca plc is seeking a Senior Specialist, QA IT to provide independent QA oversight for GxP computerised systems across their lifecycle. You will partner with process owners, IT, Digital, Data and suppliers to ensure solutions are compliant, secure and reliable.

You will apply regulatory requirements, AstraZeneca standards and industry best practice to enable validated delivery, operation, changes and retirement of technology used in regulated activities.

Qualifications

• Provides QA oversight for GxP computerised systems across their lifecycle.
• Approves intended use, GxP impact, risk assessments and validation/assurance plans.
• Ensures data integrity controls meet ALCOA++ principles including access control and audit trails.
• Oversees incidents, deviations, CAPAs, changes and supplier issues.
• Escalates risks with independent Quality decisions and clear communication.

Responsibilities

• Acts as QA IT lead for assigned GxP systems portfolio.
• Determines proportionate assurance pathway based on impact and complexity.
• Reviews architecture and control design from a Quality perspective.
• Assesses supplier capability and evidence, supports audits.
• Maintains validated state through monitoring, access reviews and patch assessment.
• Leads or supports investigations into significant system failures and data integrity concerns.
• Provides coaching to project teams on computerised-system assurance and inspection readiness.

Skills

QA oversight

GxP compliance

Lifecycle-based approach

Regulatory requirements

Data integrity (ALCOA++)

Audit readiness

Risk assessment

Stakeholder collaboration

Quality decision-making

Coaching and training

Job description

AstraZeneca plc is seeking a Senior Specialist, QA IT to provide independent QA oversight for GxP computerised systems across their lifecycle. You will partner with process owners, IT, Digital, Data and suppliers to ensure solutions are compliant, secure and reliable.

You will apply regulatory requirements, AstraZeneca standards and industry best practice to enable validated delivery, operation, changes and retirement of technology used in regulated activities.